Author + information
- Received November 22, 2009
- Revision received February 16, 2010
- Accepted February 21, 2010
- Published online May 1, 2010.
- Joshua M. Stolker, MD⁎,
- Elizabeth M. Mahoney, ScD⁎,
- David M. Safley, MD⁎,
- Frank B. Pomposelli Jr, MD†,
- Jay S. Yadav, MD‡,
- David J. Cohen, MD, MSc⁎,⁎ (, )
- on behalf of the SAPPHIRE Investigators
- ↵⁎Reprint requests and correspondence:
Dr. David J. Cohen, Saint Luke's Mid America Heart Institute, 4401 Wornall Road, Kansas City, Missouri 64111
Objectives This study compared health-related quality of life in patients undergoing carotid artery stenting (CAS) versus surgical endarterectomy (CEA).
Background Carotid artery stenting is approved in the U.S. for treating carotid stenosis in patients at high surgical risk. Whether CAS offers advantages in terms of other patient-centered outcomes is unknown.
Methods We evaluated health-related quality of life in the SAPPHIRE (Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy) trial, which randomized 334 high-risk patients with carotid stenosis to CAS versus CEA. Health status assessments were obtained at baseline; 2 weeks; and 1, 6, and 12 months after revascularization. Generic measures included the Short-Form-36 (SF-36) (0 to 100 scale), general health rating, and EuroQol (EQ-5D). In addition, we used 6 disease-specific modified Likert scales to assess difficulty with walking, eating/swallowing, driving, headaches, neck pain, and leg pain.
Results In patients treated according to protocol (n = 159 CAS; n = 151 CEA), CAS patients had better scores at 2 weeks for the SF-36 role physical scale (mean difference: 9.0; 95% confidence interval: 0.9 to 17.1; p = 0.031), but these differences had resolved by 1-month follow-up. For the disease-specific scales, CAS patients reported less difficulty eating/swallowing at 2 weeks, less difficulty driving at 2 weeks, and less neck pain at 2 weeks; each of these differences between groups was no longer present at 1 month. No other scores differed between groups at any time point.
Conclusions Among patients at high surgical risk, CAS was associated with less health status impairment during the first 2 weeks of recovery when compared with CEA. However, these differences had resolved by 1 month after the procedure, and no other differences between revascularization strategies in health-related quality of life were found.
The SAPPHIRE trial and its quality of life substudy were supported by grants from Cordis Corporation (a subsidiary of Johnson & Johnson). The study agreement stipulated that the investigators would have full access to the dataset and the right to publish the study's results, regardless of the findings. Dr. Stolker has served as a consultant to Novo Nordisk and Educational Testing Consultants and has served on the Speakers' Bureau for AstraZeneca and Pfizer Pharmaceuticals. Dr. Safley has served on the Speakers' Bureau for Abbott Vascular. Dr. Yadav is the inventor of the Angioguard emboli-protection device used in the SAPPHIRE trial and was a shareholder in Angioguard, Inc. at the time of its purchase by Johnson & Johnson in 1999; he receives recurring payments from Johnson & Johnson as a former shareholder of Angioguard, Inc.; he does not own any shares of stock in Johnson & Johnson. Dr. Cohen has received research support from and serves as a consultant to Cordis, Inc.
- Received November 22, 2009.
- Revision received February 16, 2010.
- Accepted February 21, 2010.
- American College of Cardiology Foundation